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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VANCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VANCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A60P9B
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the units involved with this complaint and completed the device evaluations. Failure analysis investigations are as follows: the reported failure could not be reproduced on the pmsc. The board was installed into pca test system and a video test was ran along with 10 power cycles and sitting idle for one hour. Failure analysis repaired the power video on the monitor hrsv. The ic caps were replaced. All functions were tested and a backlight calibration was performed. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Manufacturer Narrative
Isi received the units involved with this complaint, however, the failure analysis investigation is still in progress and therefore the root cause of the customer reported failure has not been determined. A follow up mdr will be submitted once the failure analysis has been completed and/or additional information is received. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur, it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vanci-assisted total benign hysterectomy procedure, the customer experienced a black image in the right eye. The customer performed an emergency power off (epo) on the surgeon side console (ssc) and reseated the blue fiber cable. The system would power up normally but there was no image output in the right eye of the ssc. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) contacted the initial reporter and obtained the following additional information: it was confirmed that the surgeon successfully completed the procedure without patient harm using only one eye. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure. The fse replaced the personality module surgeon console (pmsc) and the high resolution stereo viewer (hrsv). The pmsc is a module that consists of 5 interface boards. The fse replaced the pmsc and the hrsv to repair the system. The hrsv provides the video image for the ssc.
 
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Brand NameDA VANCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key6673328
MDR Text Key252012022
Report Number2955842-2017-00400
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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